Estradiol treatment for advanced breast cancer with specific mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of 17b-estradiol therapy in patients with ESR1-mutant or amplified metastatic breast cancer compared to those with ESR1-wild-type breast cancer. Eligible participants are post-menopausal women with endocrine-resistant breast cancer who have previously received at least one line of endocrine therapy. The treatment phase involves administering estradiol until disease progression, followed by an optional observational phase where patients may receive subsequent treatments at their oncologist's discretion. The study will assess clinical benefits, progression-free survival, and various biomarkers to understand treatment responses better.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Post-menopausal women with ER+ breast cancer.
* Metastatic or locoregional recurrence not amenable to treatment with curative
* intent.
* Received ≥1 prior line of endocrine-based therapy (e.g., including tamoxifen, aromatase inhibitors, fulvestrant, or combinations) in the advanced/metastatic setting

Exclusion Criteria:

* During the study Treatment Phase with 17b-estradiol, no concurrent anti-cancer therapies are allowed with the following exceptions:

  * Exception: Trastuzumab is allowed for the treatment of subjects with a history of HER2+ disease, and will be used at the physician's discretion.
  * Exception: Anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) are permitted.
* Any investigational cancer therapy in the last 3 weeks.
* Known CNS disease, unless clinically stable for ≥ 3 months.
* History of any of the following:

  * Deep venous thrombosis.
  * Pulmonary embolism.
  * Stroke.
  * Acute myocardial infarction.
  * Congestive heart failure.
  * Previous malignancy not treated with curative intent, or with an estimated recurrence risk ≥30%.

Where it's running

• Dartmouth-Hitchcock Medical Center
  Lebanon, New Hampshire, United States Recruiting

Study contacts

• Principal investigator: Muhammad Azfal, MD — Dartmouth-Hitchcock Medical Center
• Study coordinator: Research Nurse
• Email: Cancer.Research.Nurse@dartmouth.edu
• Phone: 1-800-639-6918

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.